País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)
California Pharmaceuticals LLC
PANTOPRAZOLE SODIUM
PANTOPRAZOLE 40 mg
ORAL
PRESCRIPTION DRUG
Pantoprazole sodium delayed-release tablets, USP are a proton pump inhibitor indicated for the following: - Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1) - Maintenance of Healing of Erosive Esophagitis (1.2) - Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (1.3) 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole sodium delayed-release tablets, USP are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets, USP may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. 1.2 Maintenance of Healing of Erosive Esophagitis Pantoprazole sodium delayed-releas
How Supplied Pantoprazole sodium delayed-release tablets, USP, 40 mg, are supplied as light yellow to yellow color, oval shaped, biconvex, delayed-release tablets imprinted “A37” with black ink on one side and plain on the other side. They are available as follows: Bottles of 7 NDC 70332-300-01 Bottles of 30 NDC 70332-300-02 Storage Store pantoprazole sodium delayed-release tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
PANTOPRAZOLE SODIUM- PANTOPRAZOLE TABLET, DELAYED RELEASE CALIFORNIA PHARMACEUTICALS LLC ---------- PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS 1 INDICATIONS AND USAGE Pantoprazole sodium delayed-release tablets, USP are a proton pump inhibitor indicated for the following: Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1) Maintenance of Healing of Erosive Esophagitis (1.2) Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (1.3) 1.1 SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GASTROESOPHAGEAL REFLUX DISEASE (GERD) Pantoprazole sodium delayed-release tablets, USP are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets, USP may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. 1.2 MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS Pantoprazole sodium delayed-release tablets, USP are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months. 1.3 PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME Pantoprazole sodium delayed-release tablets, USP are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. 2 DOSAGE AND ADMINISTRATION INDICATION DOSE FREQUENCY SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD (2.1) Adults 40 mg Once Daily for up to 8 wks Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once Daily for up to 8 wks ≥ 40 kg 40 mg MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS (2.1) Adults 40 mg Once Daily* PATHOLOGICAL HYPERSECRETORY CONDIT Leia o documento completo